Sii Pneumosil Drug Interactions

SII PNEUMOSIL (10-valent) can be given with any of the following vaccine antigens, either as monovalent or combination vaccines: diphtheria, tetanus, whole-cell pertussis, Haemophilus influenzae type b, inactivated or oral poliomyelitis, rotavirus, yellow fever, hepatitis B, measles and rubella. Clinical studies demonstrated that the immune responses and the safety profiles of the administered vaccines were unaffected. Studies with other pneumococcal conjugate vaccines coadministered with mumps, varicella, meningococcal ACWY and rotavirus vaccines have demonstrated that the immune responses of the other pneumococcal conjugate vaccines and the co-administered vaccines were unaffected.
Based on experience with use of other pneumococcal conjugate vaccines, SII PNEUMOSIL can be given concomitantly with acellular pertussis antigen.
In clinical trials, when other pneumococcal conjugate vaccines were given concomitantly but at a different site/route, with rotavirus vaccine or hepatitis A vaccine, no change in the safety profiles for these infants was observed.
Based on experience with use of other pneumococcal conjugate vaccines, data from a post marketing clinical study evaluating the impact of prophylactic use of antipyretics (ibuprofen and paracetamol) on the immune response to SII PNEUMOSIL suggest that administration of paracetamol concomitantly or within the same day of vaccination may reduce the immune response to SII PNEUMOSIL after the infant series. Responses to the booster dose administered at 12 months were unaffected. The clinical significance of this observation is unknown.
Different injectable vaccines should always be given at different injection-sites. Till date SII PNEUMOSIL (10-valent) clinical studies have been conducted in India and The Gambia in toddlers and infants.
In the Gambia Phase ¹/₂ study, there was no evidence that administration of SII PNEUMOSIL (10-valent) interfered with the immune response to any component of co-administered pentavalent vaccine.
In the Gambia Phase 3 study, non-inferiority of the immune responses induced by EPI vaccines between treatment groups was demonstrated for all EPI vaccines co-administered during the 3-dose primary vaccination series (6 weeks, 10 weeks and 14 weeks) - namely, whole-cell pentavalent vaccine (DTwP-HepB-Hib) oral polio vaccine, inactivated polio vaccine, and oral rotavirus vaccine. Standard EPI vaccines based on the Gambian EPI schedule (measles-rubella vaccine and yellow fever virus vaccine) were co-administered with the booster dose of study vaccine. Non-inferiority of the immune responses was demonstrated for these co-administered EPI vaccines. While there are no known published data on co-administration of other pneumococcal conjugate vaccine with yellow fever virus vaccine, the high seroresponse rate to yellow fever in the SII PNEUMOSIL (10-valent) group indicates that SII PNEUMOSIL (10-valent) does not interfere with the immune response to yellow fever virus vaccine.